Executive Briefing Series (formerly The Food & Drug Letter)

The additional funds obtained by the FDA in the past few years, due to new programs in the 2007 FDA Amendments Act, the 2009 Family Smoking Prevention and Tobacco Control Act and the 2011 Food Safety Modernization Act have allowed the agency to increase hiring of compliance investigators. From a low of 1,218 investigators in 2008, the agency had 1,600 in 2011. This helped to boost enforcement of FDA-regulated companies, yet the FDA’s production of warning letters has shifted away from drug manufacturers toward food and tobacco companies, and this shift is showing up in raw numbers. For example, CDER issued 108 drug-related warning letters in fiscal year 2011. That’s down from 171 warning letters in fiscal 2010. Similarly, CBER handed out eight warning letters in fiscal 2011, down from 15 in 2010. This issue of The Food & Drug Letter looks at good manufacturing practice (GMP)-based drug warning letters the FDA issued in 2011, discussing the most common violations and offering suggestions for drug companies to help avoid receiving Form 483 inspectional observations and the warning letters that often follow those inspections.

While warning letter summaries show the specific regulations for which companies are being cited, a deeper look at inspectional findings reveals the following five overarching topics leading to organizations getting warning letters:

Amid concern that continued breaks in the global supply chain will put the public safety at risk, FDA inspectors are boosting scrutiny of drug and device manufacturers’ supplier controls to ensure they are sufficiently robust and clearly articulated in scientific terms – and to ensure that these standard operating procedures (SOPs) are followed.

The FDA signaled a change in philosophy in 2010 and 2011 – an increased emphasis on holding pharmaceutical executives accountable for a company’s violations.

In assessing violations and determining the need for warning letters, the FDA is also paying increased attention to a company’s internal corporate compliance program.

Most warning letters begin with a Form 483.